Description

Dezocine Impurity 2 is a specified impurity of the analgesic pharmaceutical Dezocine, identified by CAS No. 100667-17-2. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and analytical chemistry industries who require reliable materials for ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dezocine-related impurities.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, and GC methods for impurity profiling of Dezocine Active Pharmaceutical Ingredient (API).
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to meet ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies of Dezocine to monitor impurity formation over time.
• Research & Development: Used in synthetic chemistry R&D for route scouting and process optimization to minimize this specific impurity.

Basic Information

Product Name	Dezocine Impurity 2
CAS No.	100667-17-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dezocine Related Compound 2; Dezocine EP Impurity B; Dezocine USP Impurity; (1R,5R,9R)-5,9-Dimethyl-2'-hydroxy-2-(3-methylbut-2-en-1-yl)-6,7-benzomorphan; 2'-Hydroxy-5,9-dimethyl-2-(3-methyl-2-butenyl)-6,7-benzomorphan; Dezocine Impurity B; Dezocine Specified Impurity
EINECS	Contact for details

Quality Control

Our Dezocine Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.